| CTRI Number |
CTRI/2025/04/084729 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the esthetics of dental implants in the anterior teeth region using customized and standard gingival formers A randomized trial |
|
Scientific Title of Study
|
Esthetic outcomes of delayed implant placement in the anterior zone with customized and prefabricated gingival formers a Randomised control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahima Ahuja |
| Designation |
postgraduate student dept of prosthodontics |
| Affiliation |
Manipal college of dental sciences managlore |
| Address |
Manipal college of dental sciences
Department of prosthodontics crown and bridge
room 5A
Kasturba medical college
Light house hill road
hampankatta Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09811995004 |
| Fax |
|
| Email |
mahima.ahuja242@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Y Pai |
| Designation |
Associate professor |
| Affiliation |
Manipal college of dental sciences managlore |
| Address |
Manipal college of dental sciences
Department of prosthodontics crown and bridge
room 5A
Kasturba medical college
Light house hill road
hampankatta Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8073776371 |
| Fax |
|
| Email |
pai.umesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima Ahuja |
| Designation |
postgraduate student dept of prosthodontics |
| Affiliation |
Manipal college of dental sciences managlore |
| Address |
Manipal college of dental sciences
Department of prosthodontics crown and bridge
room 5A
Kasturba medical college
Light house hill road
hampankatta Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09811995004 |
| Fax |
|
| Email |
mahima.ahuja242@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal college of dental sciences
Department of prosthodontics crown and bridge
room 5A
Kasturba medical college
Light house hill road
hampankatta Mangalore-575001 karnataka ,India |
|
|
Primary Sponsor
|
| Name |
Manipal college of dental sciences Mangalore |
| Address |
Manipal college of dental sciences
Department of prosthodontics crown and bridge
room 5A
Kasturba medical college
Light house hill road
hampankatta Mangalore-575001 karnataka ,India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahima Ahuja |
Manipal college od dental sciences Mangalore |
Manipal college of dental sciences
Department of prosthodontics crown and bridge
room 5A
Kasturba medical college
Light house hill road
hampankatta Mangalore
Dakshina Kannada
KARNATAKA |
9811995004
mahima.ahuja242@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committe MCODS mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
customised gingival former |
a ready made gingival former was customised by adding composite. Time of intervention is 7-10 days. |
| Comparator Agent |
prefabricated gingival former |
ready made gingival former
the one without any composite.
Time of intervention is 7-10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18yrs
Single implant placement in the anterior esthetic zone (maxilla)
Delayed extraction site with adequate bone volume
Implants placed after a defined period of delayed extraction
Healthy gingival tissue without severe periodontal disease
Standardized photographic documentation
Evaluation using esthetic assessment tools
Informed consent and willingness to adhere to postoperative care |
|
| ExclusionCriteria |
| Details |
Smokers or heavy smokers
Significant systemic diseases affecting healing or implant success
Severe bone defects requiring extensive grafting
Unrealistic esthetic expectations |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PINK AND WHITE ESTHETIC SCORE |
4-5 months from the date of implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Soft tissue changes & patient satisfaction |
6 to 7 months from implant placement so basically 1 week after final prosthesis fabrication |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Participant Recruitment: 20 participants meeting the inclusion criteria will be recruited from a pool of patients seeking implant therapy. 2. Group Assignment: Continuous or sequential randomization will be used .Continuous or sequential randomization is a method used when participants are enrolled in a study over time rather than all at once. In this approach, as participants are recruited, they are randomly assigned to treatment groups. It ensures that each participant has an equal chance of being assigned to any treatment group at the time of enrollment. Participants will be randomly assigned to either Study Group 1 (Customized Gingival Formers) or Study Group 2 (Prefabricated Gingival Formers). 10 patients in each group. |